Kornimate/medical-research-clean huggingface dataset:
reversal agent use in patients treated with direct oral anticoagulants or vitamin k antagonists

Conditions: Severe Bleeding; Urgent Surgery

Summary: patients treated with vitamin k antagonists (vka) or direct oral anticoagulants as rivaroxaban, apixaban, edoxaban or dabigatran, who experience severe bleeding and/or need urgent interventions/operations that cannot wait are included in this registry, or during emergency operations.

the registry will offer the opportunity to evaluate the effects of reversal agents as pcc, apcc, rviia, specific antidots in e.g. severe bleeding patients treated with oral anticoagulants. by collecting case reports from several university hospitals and clinics, different treatment strategies in clinical practice will be observed and evaluated, and may serve as a comprehensive information resource for the safe management with doa, but also with the long-term anticoagulation based on coumarin derivatives in the near future. the current objective of this registry is to: 1. document the clinical course and outcome of various clinical bleeding events associated with doa or vka in patients with severe life-threatening bleeding making intervention necessary 2. document the clinical course and outcome of urgent surgical interventions within 24 hours after admission in patients under doa or vka treatment. 3. characterisation of therapeutic strategies in stopping acute life-threatening bleeding including following agents and methods: 1. blood transfusion, 2. platelet concentrates 3. reversal agents \[e.g. vitamin k, prothrombin complex concentrate (pcc), activated pcc (apcc), activated factor vii (avii), fibrinogen concentrate, fresh frozen plasma (ffp)\] 4. specific antidots, e.g. idarucizumab 5. haemodialysis 6. desmopressin 7. tranexamic acid 8. no specific treatment in respect to the above mentioned treatments (e.g. stop of medication and waiting until anticoagulant effect of doa is decreased).

Eligibility criteria:
patient eligibility 1. a) bleeding patients: anticoagulated patients with doa or vka with clinically overt major bleeding according to a specified isth definition for non-surgical patients: * symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome * bleeding causing a fall in hemoglobin level of 2 g l-1 (1.24 mmol l-1 ) or more leading to transfusion of two or more units of whole blood or red cells. or b) acute surgical need patients treated with doa or vka and who need urgent operation which cannot wait (\< 24 h after last intake of drug) and 2. with or without reversal agent use (e.g. pcc, apcc, rviia) (and/or haemodialysis for dabigatran) and 3. provides informed consent after the acute event

Keywords: severe bleeding dabigatran rivaroxaban apixaban edoxaban pcc apcc rviia hemodialysis antidots idarucizumab
frozen embryo transfer with gnrh-antagonist trial

Conditions: Infertility

Summary: the fertility treatment in vitro fertilisation (ivf), sometimes including intra-cytoplasmic sperm injection (icsi), involves the creation of embryos in a laboratory. these embryos are then transferred into the womb of the patient with the hope of a resulting pregnancy and live birth. embryos can also be cryopreserved (frozen) and stored, and then later replaced in a cycle called frozen embryo transfer (fet). there are several methods of preparing the patient's womb to receive the frozen-thawed embryo(s) but commonly embryos are replaced during a medicated cycle. usually oestrogen and progesterone are administered to prepare the womb lining for embryo transfer at the appropriate time, and in addition a drug called a gnrh antagonist is administered to prevent a women's own hormones from interfering with this process as it is thought this might lead to higher numbers of cycles being cancelled. however, there is some suspicion that this drug (gnrh antagonist) may not be required and that women are using this drug unnecessarily. some clinics do not use gnrh antagonists in fet cycles, but the investigators do not know if they have higher rates of cancelled cycles as a result. this pilot study aims to compare cycles of medicated fet using oestrogen and progesterone, either with or without pituitary suppression in the form of gnrh antagonist (cetrotide), in patients over the next 18 months who are planning fet cycles at oxford fertility, uk to find out if both give the same chance of having a baby, which treatment is better for patients and to assess the feasibility of undertaking a future larger study. cetrotide is a marketed and well-known medication and any risk or serious adverse effects are unlikely. the study is an open label prospective randomised controlled trial. funding for the medication (cetrotide) is provided by oxford fertility.


Eligibility criteria:
inclusion criteria: * willing and able to give informed consent for participation in the study. * planning to undergo medicated fet * blastocyst embryo in storage available for transfer exclusion criteria: * previously randomised into the trial. * a history of 3 or more consecutive implantation failures (after fresh or frozen embryo transfer). * a history of recurrent miscarriage (3 or more consecutive miscarriages). * contraindication to the use of medications for fet cycle. * biopsied embryos. * donor embryos or eggs (use of donor sperm is not excluded).
infectious outcomes of povidone-iodine rectal cleansing plus formalin disinfection of needle during prostate biopsy

Conditions: Prostate Cancer; Prostatic Neoplasms; Prostate Biopsy; Prostatitis

Summary: the main purpose of this study is to compare the infectious outcomes of intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy. the secondary objective is to evaluate predictive factors of infectious complications after prostate biopsy. data will be prospectively collected from patients who will undergo prostate biopsy in a single high volume urology center. the patients will be randomized to two different groups: group a - rectal cleansing and disinfection of the needle tip vs group b - controls.

prostate cancer is the most common neoplasm of solid organs in brazil. definitive diagnosis of the tumor is established through prostate biopsy, indicated in patients with elevated levels of psa or suspicious rectal examination. the ultrasound or mri-guided prostate biopsy is mostly performed through the transrectal route worldwide. although it is a relatively safe procedure, transrectal prostate biopsy (trusb) can present several complications, such bleeding, acute urinary retention or infection. infectious complications are an important concern for the urologist and have different presentation, ranging from isolated fever to severe sepsis. antibiotic prophylaxis is an effective widely used practice, however, due to increasing rates of bacterial resistance, there is a growing trend in the incidence of infectious complications after trusb. therefore, alternative strategies to decrease infections rates following biopsies are welcome. our aim was to compare the infectious complications of intrarectal povidone-iodine cleansing associated to formalin disinfection of biopsy needle tip at prostate biopsy. a prospective controlled study will be conducted enrolling 1152 consecutive prostate biopsies in a single center high volume urology brazilian public hospital. the patients will be randomized at a 1: 1 ratio for two different groups: group a - rectal cleansing and disinfection of the needle tip vs. group b - controls at transrectal ultrasound guided prostate biopsy. patients will obtain a urine culture 48 hours after biopsy and complete a telephone interview 7 days after undergoing the procedure. the primary endpoint will be the rate of infectious complications, defined as 1 or more of the following events: fever ≥37.8 ºc; urinary tract infection (uti) or sepsis (standardized definition). we will also evaluate the predictive factors of infectious complications

Eligibility criteria:
inclusion criteria: * signature of the consent term; * agreement with the study follow-up protocol; * indication of biopsy due to increased psa (\> 2.5), abnormal rectal touch or patients under active surveillance protocol exclusion criteria: * existence of cognitive deficit that impedes the reading and comprehension of the ehic; * allergy to ciprofloxacin or iodine
the impact of multimedia childbirth prediction on parturients and their spouses

Conditions: Multimedia

Summary: multimedia birth prediction intervention helps mothers and their spouses reduce the number of trips to the hospital, reduce anxiety, and increase self-confidence. a total of 83 couples were accepted for cases, with a 10% attrition rate. so, a total of 95 couples were admitted and divided into the experimental group and the intervention measures were implemented experimental group. fill out basic demographic and obstetric variables, self-confidence visual analog scale, situational-trait anxiety scale-situational anxiety part at 37 weeks of pregnancy, at the first visit to the hospital, and one hour after admission to the hospital for delivery

more than 90% of pregnant women are prone to anxiety and fear due to unexpected and uncontrollable birth signs before delivery and because they cannot control their own condition. pregnant women who receive prenatal education can reduce their fear, depression, anxiety and stress about childbirth, increase their self-confidence during childbirth, and thus gain a positive childbirth experience. as a quasi-experimental study, cases were accepted using a random method. the number of cases admitted was 83 couples, with a 10% attrition rate. therefore, a total of 95 couples were admitted and divided into an experimental group and a control group. the experimental group received intervention measures, and the control group received intervention measures. at 37 weeks of pregnancy, at the first visit to the hospital for examination, and one hour after admission, basic demographic and obstetric variables, self-confidence visual analogy scale, and situational-trait anxiety scale-situational anxiety were filled in, and statistical analysis was performed. the methods were descriptive statistics, independent t test, chi-square test, analysis of variance, generalized estimating equations, and linear regression between the experimental and control groups.

Eligibility criteria:
1. low-risk first-time mothers over 20 years old and their spouses 2. pregnancy \>37 weeks, pregnancy \<40 weeks 3. single birth, head position 4. vaginal producers 5. those who can listen, speak, read and write chinese 4. diagnosed by a doctor as prenatal mental illness 5. the fetus' condition requires admission to a moderate or severe ward or intensive care unit.

Keywords: birth signs, anxiety, self-confidence, number of home visits
study comparing imatinib with chemotherapy as induction in elderly patients with philadelphia positive acute lymphoblastic leukemia (all)

Conditions: Philadelphia Positive Acute Lymphoblastic Leukemia; Lymphoid Blastic Phase of Chronic Myeloid Leukemia

Summary: the aims of the study are to determine whether single agent imatinib (sti571; glivec) is more effective as up-front remission induction therapy than conventional multi-agent induction chemotherapy for elderly patients with philadelphia positive (ph+)all, whether this treatment is better tolerated, and whether subsequent combination therapy with imatinib and chemotherapy of approximately a 1 year duration is tolerable and effective with respect to maintaining remissions.


Eligibility criteria:
inclusion criteria: * male or female patients * age \> 55 years (biological age) * diagnosis of ph1 chromosome-positive all (pre-b, common- or pre-pre-b all) * newly diagnosed, lymphoid blast crisis of chronic myeloid leukemia * only pre-phase chemotherapy prior to study start * world health organization (who) status 0, 1 or 2 * voluntary written informed consent exclusion criteria: * creatinine levels more than 2 x the upper limit of normal (uln) * total serum bilirubin more than 1.5 x the uln * ast (sgot) or alt (sgpt) more than 5 x the uln * any other prior antineoplastic treatment except for pre-phase chemotherapy * active central nervous system (cns) leukemia * new york heart association (nyha) grade 3/4 cardiac disease * active severe infection * serious concomitant medical condition * patients with a history of non-compliance to medical regimens
mk0476 study in adult patients with allergic rhinitis (0476-378)

Conditions: Rhinitis Allergic

Summary: the clinical study evaluates the efficacy and safety of mk0476 in adult patients with allergic rhinitis.


Eligibility criteria:
inclusion criteria: * adult patients with seasonal allergic rhinitis exclusion criteria: * patients who have nasal diseases (e.g., nasal polyp, septonasal arcuation, hypertrophic rhinitis), upper respiratory infection, sinusitis, infectious rhinitis, ocular infection and those disease severe enough to interfere with assessment of effectiveness * patients who have rhinitis medicamentosa, or nonallergic rhinitis (e.g., vasomotor rhinitis, eosinophilia rhinitis) * patient has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe disease
cognitive training on sleeping disorders in stroke

Conditions: Stroke; Sleep Disorder

Summary: cognitive impairment and sleeping disturbance following stroke diagnosis are common symptoms that significantly affect the quality of life.

40 patients from both sexes will participate in this study. all the patients have to be diagnosed as stroke patients. the patients will be divided into two groups; group a (20 patients): which will receive cognitive training combined with instructive conventional treatment for a sleeping disorder, and group b (20 patients): which will receive instructive conventional treatment for sleeping disorder all the patients will be assessed pre and post-treatment using 1- epworth sleeping scale, 2-pittsburgh sleep quality index ( psqi) 3- mini mental cognitive scale

Eligibility criteria:
inclusion criteria: * stroke onset at least 5 months prior to study enrolment * with sleeping disturbance * age will range from 40:55 * upper extremity spasticity ranging from * according to modified ashowrth scale. exclusion criteria: * difficulty to communicate * other neurological conditions that cause sleeping disorders * severe depression or other psychiatric symptoms.

Keywords: stroke sleep disorders cognition
a comparative analysis of two types of exercise on outcomes following total knee arthroplasty

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study was to compare the effects of two exercise programs, using low velocity (lv) and high velocity (hv) contractions, on outcomes of individuals who have undergone total knee arthroplasty (tka). the experimental hypothesis was that individuals performing hv exercise, compared to lv, would exhibit superior outcomes.

the most effective type of exercise has not been identified for individuals who undergo total knee arthroplasty (tka). high velocity (hv) exercise when compared to low velocity (lv) exercise produces greater gains in power and certain functional activities in older adults. the use of hv exercise for patients who undergo tka has not been investigated.

Eligibility criteria:
inclusion criteria: * adults aged 60- 89 years of age. * primary unilateral tka 10-21 days prior to the outpatient pt evaluation * received inpatient rehabilitation at helen hayes hospital exclusion criteria: * any other lower extremity joint or back pain (not inclusive of recent total knee arthroplasty) rated greater than four out of ten with weight-bearing * any other lower extremity joint replacement surgery * diagnosis of osteoporosis with history of fractures, uncontrolled hypertension, unstable cardiac or pulmonary problems, neurological disease affecting motor control, uncontrolled diabetes * chest pain or shortness of breath on stair-climbing * requirement of human assistance to walk in addition to the ambulation device * inability to follow instructions to perform testing and/or exercise, * participants who stated that they would not be available to complete 12 exercise sessions * individual adherence with performance of a home exercise program (hep) less than five of seven days at the end of the treatment period

Keywords: joint replacement exercise power training
assessment of prepulse inhibition for shock pain reduction

Conditions: Pain Awareness From ICD Shocks

Summary: patient tolerance of pain from discharges of implantable cardioverter defibrillators (icd's) is highly variable. it can be influenced by psychological factors, physical condition and the number of shocks delivered. it has been shown that cutaneous pain perception can be reduced by delivery of a weak , low voltage pulse (prepulse)prior to the delivery of a stronger shock. a prepulse delivered before a high voltage icd shock will decrease discomfort compared to a shock of equal energy without a prepulse.


Eligibility criteria:
inclusion criteria: 18+ approved indication for implantation of an icd able and willing to provide informed consent independently complete and understand the mini mental state evaluation exclusion criteria: pregnancy cannot understand english or french contraindicated for defibrillation testing because of risk of thromboembolism deaf or hard of hearing, making the acute testing difficult to conduct having pain or anxiety to the extent that, in the opinion of the investigator, the results would be confounded. having a class i bradycardia pacing indication, requiring ongoing pacing support. visual problems which preclude reading the computer screen for the vas test severe musculoskeletal disorder that makes it difficult to undergo testing in the recumbent position do not achieve a score \>24/30 on a mini mental state exam

Keywords: prepulse defibrillator
efficacy of the atlas medical device on pain in patients with low back pain due to lumbar disc disease

Conditions: Lumbar Disc Disease

Summary: monocentric, comparative, randomized, controlled interventionnal study in 2 parallel groups, aiming to compare the efficacy of the atlas device with that of a standard lumbar belt on the reduction of pain felt in patients with subacute or chronic low back pain with lumbar disc disease.

the main expected benefit is a reduction in pain experienced in patients with subacute or chronic low back pain during and after wear. consequently, an improvement in the quality of daily life is expected with a less significant impact of low back pain. the main objective of the study is to compare the efficacy of the atlas medical device with a standard lumbar support belt in terms of immediate reduction of low back pain experienced in patients with subacute or chronic low back pain.

Eligibility criteria:
inclusion criteria: * patient suffering from subacute (for 6 to 12 weeks) or chronic (\> 3 months) lumbar pain; * lumbar disc disease confirmed by magnetic resonance imaging (mri) less than 3 months old; * patient with lumbar pain ≥ 40mm on the visual analogue scale (vas) at inclusion; * patient in whom a lumbar belt / restraint is considered for a short period to help resumption of activity; * patient with internet and a camera (by phone or computer) and agreeing to use them as part of the study's teleconsultations; * patient capable of understanding the information related to the study (absence of linguistic, psychological, cognitive problem, etc.), of reading the information leaflet, of completing questionnaires and agreeing to sign the consent form. exclusion criteria: * patient with neurological radicular or medullary deficits; * patient presenting a postural problem with lateralized contracture; * skin pathology in the trunk region and / or contusions and injuries by stretching the trunk; * history of spinal arthrodesis surgery; * history of cauda equina syndrome; * patient treated by implanted neurostimulation; * scoliosis with cobb angle\> 30 °; * history of recent fracture of the dorsolumbar spine (\<3 months); * history of recent rib fracture (\<3 months); * history of recent herniated disc surgery (\<3 months); * patient with diagnosed fracture osteoporosis; * patient with heart or circulatory disease or respiratory failure; * patient presenting with a tumor or infectious process of the vertebrae; * pregnant or likely to be (of childbearing age, without effective contraception) or breastfeeding; * patient participating in another clinical trial, or in a period of exclusion from another clinical trial; * patient not beneficiary of a social security scheme.
validation and evaluation of the mastication function in adults: the functional six-minute mastication test (f-6mmt).

Conditions: Mastication Disorder; Fatigue; Temporomandibular Disorder; Orofacial Pain; Chewing Problem

Summary: temporomandibular disorders (tmd) encompass various conditions that affect the temporomandibular joint and associated tissues, often causing or being associated with other symptoms such as jaw pain, myofascial pain, neck pain, and headaches. tmds are classified according to the dc/tmd instrument in which the joint and pain axes are evaluated. however, there is no evaluation of mandibular function, and tmds can result in a decrease in jaw strength and resistance. this leads to an increase in the chewing fatigue. reliable and time-effective diagnostic methods for evaluating masticatory function are crucial in the clinical setting because of the high prevalence of tmd. chewing efficiency is essential for food preparation and nutrient absorption, and muscle fatigue is a common problem affecting chewing ability. despite this, there is a lack of validated tests to evaluate chewing fatigue in patients with tmd, which makes its consideration unnoticed in clinical practice. the modified six-minute functional chewing test (f-6mmt) was proposed as a tool to evaluate chewing ability and fatigue in patients with tmd. this test is an adaptation of a previously designed test in which subjects with mitochondrial pathology were evaluated; however, the subjects were not instructed to perform functional chewing during the test. in this version, modifications are added so that the test is as functional as possible, allowing chewing to be evaluated in a standardized way, and cut-off points established between healthy subjects and subjects with tmd in terms of chewing capacity in general and fatigue in particular. this study will follow standardized reporting guidelines and recruit participants from diverse clinical settings.


Eligibility criteria:
inclusion criteria: * women and men of legal age * with or without tmds symptoms and * with or without self-reported jaw fatigue when eating exclusion criteria: * subjects treated with any type of treatment requiring infiltration of the mandibular region * participants undergoing dental interventions in the last 3 months * individuals missing two or more teeth in the same quadrant. * inability to understand or speak catalan, spanish or english.